Senior Manager of US Healthcare Regional Compliance

Edwards Lifesciences • Irvine, CA

2d • $121,000 - $170,000 • Hybrid

About The Position

At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Manager of US Healthcare Regional Compliance position is a unique career opportunity that could be your next step towards an exciting future.

The Senior Manager serves as a trusted Compliance advisor and operations lead within Edwards’ Ethics & Compliance program, providing compliance guidance for U.S. business activities including interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs). This role partners closely with business and cross-functional stakeholders to promote a culture of integrity and ensure compliance with applicable laws, regulations, industry codes, and company policies.

This collaborative, solutions-oriented compliance professional will navigate across key compliance program elements, including Compliance operations, policies, training, communications, and monitoring. Leveraging strong knowledge of the AdvaMed Code and/or PhRMA Code, the Senior Manager provides practical guidance and risk-based solutions that enable ethical decision-making and responsible business growth at Edwards Lifesciences.
This role can be a fully onsite or a hybrid role based at our Irvine, California headquarters.

Requirements

• Bachelor's Degree in related field and 10 years experience in healthcare compliance, legal, internal audit, finance or equivalent work experience based on Edwards criteria, OR
• Master's Degree or equivalent in related field and 8 years experience in healthcare compliance, legal, internal audit, finance or equivalent work experience based on Edwards criteria

Nice To Haves

• JD, CPA, CFE, CIA
• Experience working in US healthcare compliance in a large or mid-sized medical device, pharmaceutical, and/or biotech company.
• Experience working in a Big 4 (Deloitte, KPMG, PwC, EY) or mid-sized consulting firm providing healthcare compliance services to medical device, pharma or biotech companies.
• Understanding of related aspects of healthcare compliance regulations (e.g., U.S. federal anti-kickback law, False Claims Act, Sunshine Reporting Requirements, OIG Guidelines for Med Device/Pharmaceutical Manufacturers, U.S Sentencing Guidelines, AdvaMed Code of Ethics / PhRMA Code of Ethics and related regional codes of conduct on interactions with health care professionals, Foreign Corrupt Practices Act, UK Anti-Bribery Act and other related laws, rules, and regulations).
• Technical expertise across the following pillars of an effective Compliance program – operations, policies, training, communications, and monitoring
• Ability to conduct Compliance monitoring on the transactional and aggregate level on HCP/HCO activities (HCP Consulting Arrangements, Speaker Programs, External Funding activities, HCP meals and T&E, etc.)
• Knowledge of Compliance-related government enforcement trends.
• Ability to participate and present at meetings with internal and external representatives at all levels of the organization (i.e., analyst to SVP/EVP level).
• Ability to effectively present live Compliance training to small and large audiences and ability to answer Compliance questions during those trainings.
• Enterprise-wide level thinker and ability to strategize and plan for identified Compliance risks
• Proven successful project management skills.
• Proficient in Microsoft Office Suite and related tools and systems.
• Excellent documentation and communication skills and interpersonal relationship skills including partnership and collaboration management skills with ability to drive achievement of objectives.

Responsibilities

• Drive and ensure a high integrity culture by serving as a compliance business partner on US business initiatives, including (but not limited to): providing value-added and solution-oriented compliance counseling, optimizing compliance guidance/policies, and driving compliance ownership across the organization.
• Oversee the end-to-end review and approval of US HCP/HCO activities ensuring alignment with company policies, local laws and regulations, and industry codes (e.g., AdvaMed). This includes providing consultative advice, identifying and implementing refined Compliance process improvements and/or course correction/alignment opportunities, as deemed necessary.
• Update US Compliance policies, guidance, job aids, and other resources for internal stakeholders and effectively roll-out such resources, as necessary.
• Conduct live US Compliance trainings to small and large audiences and answer Compliance questions during the presentations.
• Assist and support, as necessary, US Risk Assessments, Investigations, and Monitoring of business activity and track progress to completion of corrective action plans.
• Participate in business meetings and committees, as deemed necessary. Analyze, track, and report key Compliance metrics for business leadership.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior